Chondroitin Sulfate Sodium Tablets
Chondroitin Sulfate Sodium Tablets contain NLT 90.0% and NMT 120.0% of the labeled amount of chondroitin sulfate sodium.
[NoteChondroitin Sulfate Sodium is extremely hygroscopic once dried. Avoid exposure to the atmosphere, and weigh promptly. ]
• A. Electrophoresis 726
Barium acetate buffer: Dissolve 25.24 g of barium acetate in 900 mL of water. Adjust with acetic acid to a pH of 5.0, and dilute with water to 1000 mL.
Staining reagent: 0.1% (w/v) toluidine blue in 0.1 M acetic acid
Standard solution: Use the Standard solution of middle concentration from the Content of Chondroitin Sulfate Sodium.
Sample solution: Prepare as directed in the Content of Chondroitin Sulfate Sodium.
Analysis: Fill the chambers of an electrophoresis apparatus suitable for separations on cellulose acetate membranes1 (a small submarine gel chamber or one dedicated to membrane media) with Barium acetate buffer. Soak a cellulose acetate membrane 56 cm × 1214 cm in Barium acetate buffer for 10 min, or until evenly wetted, then blot dry between two sheets of absorbent paper. Using an applicator2 suitable for electrophoresis, apply equal volumes (0.5 µL) of the Sample solution and Standard solution to the brighter side of the membrane held in position in an appropriate applicator stand or on a separating bridge in the chamber. Ensure that both ends of the membrane are dipped at least 0.51.0-cm deep into the buffer chambers. Apply a constant 60 volts (6 mA at the start) for 2 h. [NotePerform the application of solutions and voltage within 5 min because further drying of the blotted paper reduces sensitivity. ]
Place the membrane in a plastic staining tray, and with the application side down, float or gently immerse in Staining reagent for 5 min. Then stir the solution gently for 1 min. Remove the membrane, and destain in 5% acetic acid until the background clears.
Acceptance criteria: The principal spot from the Sample solution has the same migration as the principal spot from the Standard solution. [NoteDocument the results by taking a picture within 15 min of completion of destaining. ]
• Content of Chondroitin Sulfate Sodium
Standard solutions: 1.5, 1.0, and 0.5 mg/mL of USP Chondroitin Sulfate Sodium RS in water
Sample solution: Transfer an equivalent to 100 mg of chondroitin sulfate sodium from NLT 20 Tablets, finely powdered, to 60 mL of water, and shake to suspend the powder in solution. Sonicate in a 65 water bath for 20 min. Remove from the bath, stir or shake for 5 min, dilute with water to 100 mL, and centrifuge or pass through a suitable filter.
Diluent: Weigh about 297 mg of monobasic potassium phosphate, 492 mg of dibasic potassium phosphate, and 250 mg of polysorbate 80, and transfer into a 1-L beaker. Dissolve in approximately 900 mL of water, and adjust with potassium hydroxide or phosphoric acid to a pH of 7.0 ± 0.2. Dilute with water to 1 L, and mix thoroughly.
(See Titrimetry 541.)
Mode: Photometric titration
Titrant: 1 mg/mL of cetylpyridinium chloride in water
Endpoint detection: Turbidimetric with photoelectric probe
Analysis: Transfer 5.0 mL of each Standard solution and the Sample solution to separate titration vessels, and add 25 mL of Diluent to each. Stir until a steady reading is obtained with a photoelectric probe either at 420, 550, or 660 nm. Set the instrument to zero in absorbance mode. Titrate with Titrant using the photoelectric probe to determine the endpoint turbidimetrically. From a linear regression equation, calculated using the volumes of Titrant consumed versus concentrations of the Standard solutions, determine the concentration of chondroitin sulfate sodium in the Sample solution.
Calculate the percentage of the labeled amount of chondroitin sulfate sodium in the portion of Tablets taken:
Result = (C/CU) × 100
Acceptance criteria: 90.0%120.0% of the label claim
• Disintegration and Dissolution of Dietary Supplements 2040: Meet the requirements for Dissolution
Medium: Water; 900 mL
Apparatus 2: 75 rpm
Time: 60 min
Titrant and Diluent: Prepare as directed as in Content of Chondroitin Sulfate Sodium.
Standard solutions: 1.5 , 1.0, and 0.5 mg/mL of USP Chondroitin Sulfate Sodium RS in water
Sample solution: Combine equal portions of the solutions withdrawn from 6 dissolution vessels and pass through a suitable filter; use the pooled sample as the test specimen.
Analysis: Transfer 5.0 mL of each Standard solution, and an aliquot of the Sample solution equivalent to about 5 mg of chondroitin sulfate sodium, to separate titration vessels. Add 25 mL of Diluent to each titration vessel. Stir until a steady reading is obtained with a photoelectric probe. Set the instrument to zero in absorbance mode. Titrate with Titrant using the photoelectric probe to determine the endpoint turbidimetrically, either at 420, 550, or 660 nm. From a linear regression equation, calculated using the volumes of Titrant consumed versus amount, in mg, of chondroitin sulfate sodium from each Standard solution, determine the amount, in mg, of chondroitin sulfate sodium in the aliquot of Sample solution taken.
Calculate the percentage of the labeled amount of chondroitin sulfate sodium dissolved:
Result = (Ws/a) × (V/L) × 100
Tolerances: NLT 75% of the labeled amount of chondroitin sulfate sodium is dissolved.
• Weight Variation of Dietary Supplements 2091: Meet the requirements
• Packaging and Storage: Preserve in tight, light-resistant containers, and store at room temperature.
• Labeling: Label it to indicate the species of the source from which the chondroitin used to prepare the Tablets was derived. Label it to state the source(s) of chondroitin sulfate sodium, whether bovine, porcine, avian, or a mixture of any of them. The label states on the front panel the content of chondroitin sulfate sodium on the dried basis.
• USP Reference Standards 11
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USP35NF30 Page 1249Pharmacopeial Forum: Volume No. 31(1) Page 85